Clearance Summary
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) received FDA 510(k) clearance under submission number K213497, sponsored by H&abyz Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-11-15.
- Submission: K213497
- Applicant / Sponsor: H&abyz Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2021-11-15
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.